TRUFREEZE SYSTEM

K133258 · CSA Medical, Inc. · GEH · Jun 19, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133258
• Device Name: TRUFREEZE SYSTEM
• Applicant: CSA Medical, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

Device Story

The truFreeze System is a cryosurgical tool for ablating benign and malignant tissue. It consists of a mobile console with a touch panel computer, cryogen/suction/electronics modules, and a disposable spray kit containing flexible, open-tipped catheters and cryogen decompression tubes (CDT). The system applies medical-grade liquid nitrogen to the treatment area. The console manages cryogen level, pressure, cooling, defrost, and suction. Operators (physicians) control the system via a touch panel or dual foot pedal; a wireless remote provides auxiliary timer control. The CDT and on-board suction system facilitate venting of cryogen gas. By achieving temperatures of -196°C, the device creates ice balls to destroy targeted tissue. The system is used in clinical settings; output allows physicians to perform targeted tissue ablation, providing a minimally invasive surgical option for lesion destruction.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing comparing the truFreeze System to the IceSense3 predicate. Bench testing demonstrated equivalent performance in reaching lethal temperatures (-196°C vs -170°C) and producing comparable ice ball depths and temperature distributions (0°C, -20°C, -40°C isotherms) within equivalent freeze/thaw/freeze cycles.

Technological Characteristics

Cryosurgical unit using liquid nitrogen. System includes a mobile console with touch panel computer, cryogen/suction/electronics modules, and sterile single-use catheters (7 Fr) and decompression tubes. Operates via low-pressure spray. Features include cryogen level sensing, pressure relief valves, and isolated low-voltage power. Software manages timing, cooling, and suction. Connectivity includes wireless remote control. Sterilization for disposable components is implied.

Indications for Use

Indicated for patients requiring cryogenic destruction of tissue in dermatology, gynecology, and general surgery to ablate benign and malignant lesions. Requires active or passive venting during procedures.

Regulatory Classification

Identification

(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

Predicate Devices

• IceSense3 (K102360)

Submission Summary (Full Text)

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JUN 1 9 2014 csomedical.com

CSA Medical Inc. 91 Hartwell Avenue Lexington, MA 02421 781,538,4720 re 781.538.4730 lax

# 510K Summary TruFreeze® System

Applicant Establishment Registration Number Contact Person

- Summary Date Proprietary Name Classification Classification Name Regulation Number Classification Predicate Device
CSA Medical 3004534508 Sherrie Coval-Goldsmith VP RA/QA CSA Medical 91 Hartwell Ave Lexington, Ma 02142 Phone: [phone] Fax: [phone] [e-mail] June 9, 2014 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K102360 IceSense3

#### Device Description

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of (1) a console and (2) a disposable spray kit.

#### Console:

The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the- shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

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# Disposable spray kit:

The truFreeze disposable spray kit consists of 5 individually packaged sterile single-use catheters ( 7 Fr Straight Tip Catheter and one Catheter Introducer.) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing.). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.

# Intended Use/Indications for Use

The truFreeze System is similar in its Intended Use as the predicate device (K102360 IceSense3). Both devices describe the ablation of benign and malignant tissue in general terms.

The requirement to use active or passive venting is in the cleared truFreeze Instructions for Use document (K113021) and adding it to the intended use/indications for use statement highlights the importance of venting and will enhance safe use of the device. Therefore, the revised intended use/indications for use statement raises no new issues of safety or effectiveness.

The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.

The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

# Technical and Operational Characteristics

The truFreeze System is similar in design, operational and technological characteristics as the predicate device and supports that no new safety concerns are being raised by change in intended use/indications for use statement and thus raises no new issues of safety or effectiveness.

# Summary of Testing

The truFreeze System was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, software testing, animal testing, biocompatibility and sterilization testing. Since the change in:the, truFreeze, system limited to the Indications for Use, limited bench testing swas conducted to support

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demonstration of substantial equivalence in performance from the truFreeze to its predicate device. A summary table of the bench testing is provided below:

| | Bench Testing Comparison Table | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Bench Test | Proposed truFreeze System | Predicate IceSense3 | Comments |
| Characteristic | (K133258) | (K102360) | |
| Ability to reach<br>equivalent dose (using<br>same freeze/thaw/freeze<br>cycle) | 2min/2min/2min =1.8-2.4cm<br>3min/2min/3min=2.4-3.0cm<br>4min/4min/4min=3.0-3.6cm | 2min/2min/2min =2.1-2.5cm<br>3min/2min/3min=2.6-3.0cm<br>4min/4min/4min=3.1-4.0 cm | Both capable of producing<br>equivalent depth of ice |
| Output Temperature at<br>tip | -196 degree C | -170 degree C | Both achieve temperatures<br>low enough to destroy<br>malignant tissue |
| Equivalent temperature<br>distribution using the<br>radial distance from the<br>0° C isotherm (border<br>of ice ball) to the -20°C,<br>-40°C and -50°C<br>isotherms | @ freeze depth of 21.87mm<br>at 0°C<br>-20°C isotherm at 15.5mm<br>depth<br>-40°C isotherm at 11.8mm<br>depth | @ freeze depth of 22mm at<br>0°C<br>-20°C isotherm at 16.9mm<br>depth<br>-40°C isotherm at 13.4mm<br>depth | Both can produce lethal<br>ice at comparable depths |

## Rationale For Substantial Equivalence

The Intended Use/Indications for Use statement and technological characteristics of the truFreeze System and the predicate device (K102360 IceSense3) were compared. The Intended Use/Indications for Use statement of the two devices had equivalent general claims and do not raise new questions of safety and performance. Bench testing demonstrated that both devices can achieve equivalently cold temperatures in equivalent time periods to produce equivalent amounts of ice. These temperatures are cold enough to destroy unwanted benign or malignant tissue. This proposed change to the Indications for Use is well supported by a review of the peer reviewed clinical literature and are similar to those of the predicate device with the same general intended use of cryogenic destruction of benign or malignant tissue during surgical procedures.

The truFreeze device requires either active or passive venting for safe use. This is described within the previously cleared Instructions for Use document for the truFreeze device. The addition of this statement to the Intended Use/Indications for Use statement enhances the safe use of the device.

### Conclusion

Based on the label and technology comparison as well as the performance testing, the truFreeze device is substantially equivalent to the predicate device listed above.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Fleath Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2014

CSA Medical Ms. Sherrie Coval-Goldsmith Vice President, Regulatory Affairs/Quality Assurance 91 Hartwell Avenue Lexington, Massachusctts 02142

Re: K133258

Trade/Device Name: truFreeze" System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 15, 2014 Received: May 16. 2014

Dear Ms. Coval-Goldsmith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any reathardthe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Sherrie Coval-Goldsmith

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.

#### 510(k) Number (if known) K133258

Device Name truFreeze@ System

Indications for Use (Describe)

The truPreeze is intended for cryogenic destruction of ther active or passive venting during surgical procedures.

The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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